FDA Adverse Event
Injury
Summary report: N
ADVANTAGE SYSTEM
MDR report key: 3082798
·
Received April 29, 2013
Report
- Report Number
- 3005099803-2013-02808
- Event Type
- Injury
- Date Received
- April 29, 2013
- Report Date
- April 5, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH A ADVANTAGE FIT SYSTEM WAS IMPLANTED. THE IMPLANTATION DATE WAS EITHER (B)(6) 2007 OR (B)(6) 2008; TWO DEVICES WERE REPORTED BUT WITH NO CLARIFICATION AS TO WHICH DATE CORRESPONDS TO WHAT DEVICE. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183436 | ADVANTAGE SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |